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Acorda claims that Actavis submitted a marketing approval application with the U.S. Food and Drug Administration (FDA) asking permission to develop and commercialize a new drug, a generic version of Ampyra, which is an extended release medication to improve walking function in patients with multiple sclerosis.

The company now has 45 days to initiate a patent infringement lawsuit against Actavis, which is expected to result in a statutory stay period to delay the FDA in approving an Abbreviated New Drug Application (ANDA) until July, 2017 at the earliest. Acorda announced the intention to vigorously defend its intellectual property rights.

The Food and Drug Administration granted Orphan Drug Designation to Inhibikase Therapeutics’, Inc. lead product, IkT-001Pro (imatinib), to treat progressive multifocal leukoencephalopathy(PML). According to the National Institute of Neurological Disorders and Stroke, PML affects the white matter of the brain usually through a virus known as Polyomavirus JC (JC virus). If left untreated, JC virus can destroy motor neurons and cognitive ability, eventually leading to death.Multiple sclerosis patients are particularly prone to PML due to their lowered immunity from their disease and use of certain drugs.

“Multiple sclerosis can be a very disabling disease. To date, Tysabri® is our most effective treatment,” explained Dr. Jeffrey B. English, Director of Clinical Research at the MS Center of Atlanta, in a news release. “Unfortunately, it carries a risk of a life threatening brain infection that can lead to PML. There are ways to screen for PML early, but we have no effective treatments for this disease.”

To address this need, Inhibikase has been researching and developing imatinib for delivery to patients with PML. Imatinib is a host-directed protein kinase inhibitor that interferes with JC virus replication. It has also been implicated in Novartis AG’s anti-cancer drug Gleevec® to treat blood and stomach cancers. To safely deliver imatinib to PML patients by reducing the required dose and side effects, Inhibikase formulated imatinib using its proprietary technology to make IkT-001Pro. “The anti-JC virus activity of imatinib cannot be achieved by simply altering the frequency or amount of Gleevec given to patients,” said Milton H. Werner, PhD, President and CEO of Inhibikase. “Early trial work has already shown this. To succeed, we’re talking re-engineering how imatinib is absorbed and distributed in the body.” click to continue reading

The US Food and Drug Administration has just issued a report warning the general public and healthcare providers dealing with multiple sclerosis that one of the leading medications for the disease,Tecfidera (dimethyl fumarate), has been identified a possible factor in the death of an MS patient, who developed progressive multifocal leukoencephalopathy (PML) — a rare but serious brain infection caused by the John Cunningham virus in immunocompromised patients. The patient was not reported to be taking any other medications that may affect immune function. The US FDA is now requiring Biogen Idec to include this PML-related death on the drug’s label.

While Tecfidera has had a largely positive safety record, there have been some instances of death associated with the drug, such as a European patient who had been taking Tecfidera for 4 years since participating in a clinical trial who died of pneumonia. A similar case happened last year when an MS patient taking Tecfidera for 5 weeks experienced gastric upset, stopped the medication, and died also of pneumonia. At the time, the case was not ruled to be connected to the drug, but the case has sparked renewed scrutiny. In 2005, Biogen was forced to pull another MS drug called Tysabri off the market not long after its launch, because of several reports of patients who had developed PML. The drug returned to the market a year later with a risk-management program and prescribing restrictions.

While these reports highlight the relatively high risks associated with taking MS drugs, many patients are willing to take these risks in exchange for better management of this debilitating disease’s symptoms. The FDA cautions healthcare professionals prescribing Tecfidera to: Click to continue

Wednesday, November 26, 2014

“Everything You Wanted to Know about MS, BUT FORGOT to Ask”

This program took place on November 22, 2014 in Orlando Florida and was held as a live-streamed webcast as well.Listen to this program as there are many questions and answers that might benefit you or someone you know.Questions asked are from the live in-person audience and from Social Media. Some questions arrived in Spanish and were answered in Spanish and English.Click the above arrow to begin the program. Pause as needed, but do watch all.

Many symptoms of MS are not visible
to family, friends and colleagues. We often hear “But you look so good, so your
MS must not be causing problems for you”. However these “invisible symptoms”
can seriously affect how you function and relate to others. Each symptom would
take pages to explain. I will concentrate on some major points and tips for
managing these symptoms.

Fatigue is the most common MS symptom and the most misunderstood,
since everyone is fatigued at times. Therefore, people without MS may think it
is “not a big deal”. However, the MS fatigue can be every day and be overwhelming,
even often a good night’s sleep. It is often aggravated by heat and gets worse
as the day goes on. Managing fatigue is a challenge, which involves many
aspects of living, such as getting adequate sleep, keeping cool, reducing
stress, conserving energy and taking appropriate medications.

Heat intolerance often accompanies fatigue and can bring physical
(and mental) activities to a virtual stop. Keeping rested and cool are the best
remedies. Wearing light clothing, using cooling sprays, wearing cooling garments
(vest, neck collar, etc.) and staying indoors in the heat of the day are
suggestions. The heat related symptoms usually get better in 20-60 minutes,
once you find a cooler and relaxing environment.

Emotional symptoms such a stress, depression and Pseudo-bulbar affect
/PBA(Inappropriate or exaggerated crying or laughing) often call for a
combination of medication and counselling.

Caution and tips: (1) Taking anti-anxiety
medications for longer than 2-4 weeks can be problematic. (2) Counseling may be
a better option to deal with long term stress. (3) Antidepressant medication
may take a few weeks to reach the desired effects. Therefore, be patient and
get counseling in combination with medications. (4) A medication for PBA has
been FDA approved. Ask your doctor about Neudexta.

Memory and cognition problems affect about 50% of people with MS at
some point but they may be mild and not recognized early on. Once diagnosed,
the first step is to evaluate your current medication, which might be
contributing to your memory problems. Also, depression and/or anxiety might indicate
additional problems. In my opinion, medications for cognition have not been very helpful for most people
with MS. Although some doctors prescribe anti-Alzheimer drugs for MS, no drugs
are FDA approved for cognition problem in MS. I believe that cognitive
retraining may be helpful to educate MS patients how to better adapt to a
failing memory.

Stiffness or spasticity of muscles is common. Stretching exercises,
swimming, and physical therapy can help. Assistive devices are available
through an occupational therapist. In addition a variety of medications are
available. Oral Baclofen is often tried first.

Pain in MS occurs from extra stresses and strains on weak or stiff
muscles and joints. Exercise, cooling and minor analgesic medication usually
help. A second type of pain (CENTRAL PAIN) is caused directly by myelin damage.
Pain may be described as burning, pins/needles, dull aching, sharp (including
facial pain/trigeminal neuralgia), band like or stabbing. A variety of
medications, often those used for the treatment of epilepsy may help.. Acupuncture,
biofeedback and often relaxation therapies may also help. Narcotics are usually
not helpful and can result in addiction. Cannabis use is still controversial
and is NOT legal in most states. Long term cannabis effects on cognition in MS
are a major concern for me.

Trouble speaking or swallowing occurs in 20-25% of people with MS.
Speech therapists are qualified to diagnose and treat these symptoms. Ask for a
referral.

Bladder, bowel and sexual dysfunction are very common but
underdiagnosed and undertreated. The unfortunate reluctance to discuss these
problems with health care professionals is unfortunate because they can usually
be treated with significant reduction in these symptoms. They are often
associated with social isolation and a lower quality of life, if not treated. Specific
recommendations are numerous. A major positive influence is a shared Communication
between people with MS, their families and their health care provider. Tell the
doctor it like it! Be specific! Be direct! Talk about how it affects your life and
the lives of your loved ones. This
process can lead to better treatment and understanding (and intimacy) with your
loved ones.

In Summary, many “invisible symptoms” can be treated. The key is to
make your health care profession aware of these problems and ask for specific
recommendations and/or referral to specialists.

Transcranial magnetic stimulation (TMS) is a noninvasive method to cause depolarization or hyperpolarization in the neurons of the brain. TMS uses electromagnetic induction to induce weak electric currents using a rapidly changing magnetic field; this can cause activity in specific or general parts of the brain with little discomfort, allowing for study of the brain's functioning and interconnections. According to the United States National Institute of Mental Health, TMS "uses a magnet instead of an electrical current to activate the brain. An electromagnetic coil is held against the forehead and short electromagnetic pulses are administered through the coil. The magnetic pulse easily passes through the skull, and causes small electrical currents that stimulate nerve cells in the targeted brain region. Because this type of pulse generally does not reach further than two inches into the brain, scientists can select which parts of the brain will be affected and which will not be. The magnetic field is about the same strength as that of a magnetic resonance imaging (MRI) scan."[1] A variant of TMS, repetitive transcranial magnetic stimulation (rTMS), has been tested as a treatment tool for various neurological and psychiatric disorders including migraine, stroke, Parkinson's disease, dystonia, tinnitus and depression.

Early attempts at stimulation of the brain using a magnetic field included those, in 1910, of Silvanus P. Thompson in London.[2] The principle of inductive brain stimulation with eddy currents has been noted since the 20th century[citation needed]. The first successful TMS study was performed in 1985 by Anthony Barker and his colleagues at the Royal Hallamshire Hospital in Sheffield, England.[3] Its earliest application demonstrated conduction of nerve impulses from the motor cortex to the spinal cord, stimulating muscle contractions in the hand. As compared to the previous method of transcranial stimulation proposed by Merton and Morton in 1980[4] in which direct electrical current was applied to the scalp, the use of electromagnets greatly reduced the discomfort of the procedure, and allowed mapping of the cerebral cortex and its connections.

Medical uses

The uses of TMS and rTMS can be divided into diagnostic and therapeutic uses.

Treatment

For neuropathic pain, a condition for which evidence-based medicine fails to treat a significant number of people with the condition, high-frequency (HF) rTMS of the brain region corresponding to the part of the body in pain, is effective.[10]

For treatment-resistant major depressive disorder, HF-rTMS of the left dorsolateral prefrontal cortex (DLPFC) is effective and low-frequency (LF) rTMS of the right DLPFC has probably efficacy.[10][11] The American Psychiatric Association,[12]:46 the Canadian Network for Mood and Anxiety Disorders,[13] and the Royal Australia and New Zealand College of Psychiatrists have endorsed rTMS for trMDD.[14]

Dr Burks reviewed over 30 potential new therapies which are
in the process of being tested for people with MS. They included:

Stem
cell research for MS reveals considerable interest and preliminary results that
demonstrate the ability to generate stem cells from bone marrow, fat tissue and
skin tissue that have the potential to help restore damaged MS brain, including
myelin. Clinicals trials are ongoing. However, we must await the results of these
trials and FDA approval before commercial use. Foreign “Stem cell cures for MS”
Centers are not recommended because of lack of knowledge, acceptable clinical
trial data, and regulations to assure safety and efficacy.

*

Lemtrada
(Alemtuzumab) has been recently FDA approved for relapsing forms of MS. Dr
Burks reviewed the superior efficacy data compared to a FDA approved
Interferon, the convenience of needing only 5 IV treatments (on consecutive
days) in the first year and the caution of adverse events that necessitate
close monitoring.

Plegridy
has also been recently approved by the FDA for relapsing MS. It is effective and
safe, while only requiring a subcutaneous injection once every two weeks. The
side effects are similar to other interferons given subcutaneously.

Many
other treatments are being tested. Most are aimed at reducing the MS damage in
the Central Nervous System (CNS).Examples include:

1.Monoclonal antibodies that target “B
lymphocytes”, instead of the “T lymphocytes”. This approach attacks another
part of the immune system that may damage the CNS.

2.Vaccine type medications

3.Medications that are already FDA
approved for relapsing MS are now being tested in non-relapsing progressive
forms of MS (SPMS and PPMS)

6. Medications similar to currently approved MS therapies,
but which may have fewer side effects

7.Medications that may reduce
degeneration of brain cells, not just inflammation

8.Medications that have been used in
other diseases are being “repurposed” to treat MS.

9.Medications to increase myelin that
has been damaged

10.Vitamin D is being studied to better
determine its potential usefulness in MS

11.A low salt diet is another method to
reduce inflammation in MS

12.Re-equilibrating the bacteria in the
intestines is another novel approach to MS therapy that is just now beginning
to be explored (Microbiomes)

In summary, many new potential treatments are becoming available and more are in the early stages of testing. Many of these new medications are targeting the progressive forms of MS, as well as relapsing MS.

The future for MS therapy has never looked brighter.To watch this presentation, click here

The label for Biogen Idec Inc. (BIIB)’s multiple sclerosis drug Tecfidera will be updated with information about a patient who died of a rare brain infection while taking the medicine, U.S. regulators said today.

The drug label, which gives doctors and patients information about the drug, will now detail a case of progressive multifocal leukoencephalopathy, or PML, the Food and Drug Administration said. Biogen originally disclosed the patient’s death in October, while discussing third-quarter financial results.

Tecfidera was Cambridge, Massachusetts-based Biogen’s top-selling drug in the third quarter, earning $787 million. Analysts said last month that the death wasn’t a cause for major concern, since 100,000 patients have already been treated with Tecfidera without developing PML.

The patient who died had a very low white blood cell count, which can weaken the immune system and increase the risk of PML, according to the FDA. The agency has recommended that physicians monitor Tecfidera patients’ white blood cell counts.

With more states approving the use of medical marijuana, we examine current therapies for spasticity caused by MS and compare them to Sativex, a cannabis derivative in phase III trials that’s been fast-tracked by the FDA.

Written by Jeri Burtchell | Published on November 10, 2014

Oregon, Alaska, and Washington, D.C., voted in favor of legalizing marijuana last Tuesday, bringing the number of states that have decriminalized the drug or made special provisions for medicinal use to 23 (plus the District of Columbia). For people who suffer from conditions like cancer, Parkinson’s disease, seizures, or multiple sclerosis (MS) this news could bring relief. Medical marijuana is another tool in a doctor’s arsenal to help these patients fight their personal battles.

Research on the use of marijuana to treat symptoms of MS has been limited, but some studies in the past decade have shown that marijuana relieves MS spasticity.

What Is Spasticity?

According to the National MS Society, spasticity refers to muscle spasms and feelings of stiffness. It is a common symptom in people who have MS.

When MS damages the nerves that control muscles, it can result in spasticity that impairs movement and causes pain and stiffness. It usually occurs in the legs and can draw them up toward the body with painful cramping or cause spasms in the lower back.

For some patients who have muscle weakness, spasticity can be beneficial to a degree, as it provides them with the stiffness needed to walk. But when it gets out of control and the pain becomes too much to bear, it may be time to consider medication.

Dr. Vijayshree Yadav has studied the use of alternative medicine in MS for many years. In 2011, she wrote, “In a review of six controlled studies evaluating a combination of THC and CBD [the active ingredients in cannabis] for spasticity in MS, it was found that THC–CBD was well tolerated and improved patient self-reports of spasticity.”

Treatment Options for Spasticity

There are just three medications that have been approved by the U.S. Food and Drug Administration (FDA) specifically to relieve MS spasticity: Zanaflex, Baclofen, and Botox. Many other medications are used off-label to treat spasticity, too. The following sections outline how each of them works, how they are taken, and their possible side effects.

Added to this lineup is an oral spray called Sativex, which contains a derivative of medical marijuana. It is made by GW Pharmaceuticals and is available by prescription in 15 countries to treat MS spasticity. In April of this year, the FDA fast-tracked Sativex in the United States. Currently in phase III trials, it may soon be another FDA-approved choice for people with spasticity to consider.

SYMPTOMS of MS

In multiple sclerosis , damage to the myelin in the central nervous system (CNS), and to the nerve fibers themselves, interferes with the transmission of nerve signals between the brain and spinal cord and other parts of the body. This disruption of nerve signals produces the primary symptoms of MS, which vary depending on where the damage has occurred.

Over the course of the disease, some symptoms will come and go, while others may be more lasting.

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